Table 1 Clinical trials combining RT and immune checkpoint blockade for HNSCC.
Study identifier | Disease type | Phase | Design | Primary endpoint |
|---|---|---|---|---|
NCT03799445 | Locally advanced | II | RT + immune checkpoint inhibition (nivolumab + ipilimumab) | DLTs, CR rate (6 months) and PFS (2 years) |
NCT03509012 | Locally advanced | I | RT + cisplatin + durvalumab | DLTs (28 days post therapy) and AEs (90 days post therapy) |
NCT03426657 | Locally advanced | II | RT + durvalumab + tremelimumab | Feasibility, tumor-infiltrating CD8+ T cells and DLTs |
NCT0351906 | Locally advanced | I/II | RT + cetuximab + durvalumab | PFS (2 years) |
NCT02999087 | Locally advanced | III | Arm 1: RT + cisplatin | PFS (6 years) |
Arm 2: RT + cisplatin + avelumab | ||||
NCT02764593 | Locally advanced | I | Arm 1: Cisplatin + nivolumab | Dose-limiting toxicity (28 days post therapy) |
Arm 2: High dose cisplatin + nivolumab | ||||
Arm 3: Cetuximab + nivolumab | ||||
Arm 4: RT + nivolumab | ||||
NCT03623646 | Locally advanced | II | Arm 1: RT + cisplatin | Progression (1 year) |
Arm 2: RT + durvalumab | ||||
NCT03546582 | Recurrent or second primary | II | Arm 1: SBRT + pembrolizumab | PFS (2 and 5 years) |
Arm 2: SBRT | ||||
NCT03522584 | Recurrent or Metastatic | I/II | SBRT + durvalumab + tremelimumab | Safety and AEs (2 years) |
NCT03317327 | Recurrent or second primary | I/II | RT + nivolumab | AEs (6 months post therapy) |
NCT03212469 | Metastatic | I/II | SBRT + durvalumab + tremelimumab | DLTs |
NCT03085719 | Metastatic | II | Arm 1: High dose RT + pembrolizumab | ORR (1 year) |
Arm 2: High dose + low dose RT + pembrolizumab | ||||
NCT02684253 | Metastatic | II | Arm 1: Nivolumab | BOR (96 weeks) |
Arm 2: SBRT + nivolumab | ||||
NCT03283605 | Metastatic | I/II | RT + immune checkpoint inhibition (durvalumab + tremelimumab) | Acute toxicity (3 months) and PFS (6 months) |
NCT03313804 | Advanced or metastatic | II | SBRT or fractionated RT + nivolumab or pembrolizumab or atezolizumab | PFS (6 months) |
